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Composite liquid pharmaceutical composition comprising crude drug-stabilizing dried powder

a technology of compound liquid and pharmaceutical composition, which is applied in the direction of plant/algae/fungi/lichens ingredients, dispersed delivery, and aerosol delivery, etc., can solve the problems of increasing the risk of tuberculosis, deteriorating the productivity and deteriorating the quality of life of those around the patient, etc., to achieve excellent storage stability, high storage stability, and excellent storage stability of the main componen

Inactive Publication Date: 2019-01-17
YANG JI CHEM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a liquid pharmaceutical composition containing a Hedera helix leaf extract and a stabilized dry powder of Pelargonium sidoides. The stabilized powder is a mixture of Piaargonium sidoides extract and maltodextrin. The Pelargonium sidoides extract is extracted using water or a combination of water and organic solvent, such as C1-3 lower alcohols or acetone. The main component of the extract is a water soluble component, which is preferably ethanol. The present invention has high storage stability of the main components of both the Pelargonium sidoides extract and the Hedera helix leaf extract in the liquid phase. This allows for the preparation of a stable liquid pharmaceutical composition containing both extracts.

Problems solved by technology

Although respiratory diseases vary in degree depending on specific diseases, they all cause a deterioration in quality of life.
In severe cases, respiratory diseases render patients dependent on other people for their daily activities, leading to deterioration in productivity and quality of life for those around the patients.
Excessive inflammatory responses due to bronchitis cause complications, which may increase the risk of developing tuberculosis, acute pneumonia, bronchiectasis, asthma, etc., and mainly cause bronchial edema and pain, which aggravates pain in patients.
Similar to asthma, chronic obstructive pulmonary disease involves respiratory symptoms such as dyspnea, coughing, and sputum production, which in turn impairs lung function and eventually leads to death.
Laryngitis is caused by infectious diseases collectively referred to as upper respiratory tract infections, and it is difficult to clearly distinguish laryngitis, pharyngitis, and bronchitis from one another.
Therefore, their long-term use generates drug resistance, and there is concern about aggravation of the diseases.
Further, long-term use of steroids known to be effective for inflammation are problematic due to their serious side effects.
In addition, bronchodilators and steroids are often used in combination, and since they are developed as inhaled preparations to avoid the problem of side effects of steroids, inhaled preparations exhibit poor medication adherence, as compared with oral preparations.
Therefore, it is difficult to prepare a sufficiently effective composite liquid composition including an Pelargonium sidoides extract by only securing physical stability.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

on of Stabilized Dry Powder of Pelargonium sidoides

[0051]A stabilized dry powder of Pelargonium sidoides was prepared as a mixture of 11% ethanol extract of Pelargonium sidoides and maltodextrin.

[0052]First, roots of Pelargonium sidoides were washed to remove contaminants, dried well and then used in preparation of the extract. 2 kg of 35% by weight of an ethanol aqueous solution was added to 1 kg of roots of Pelargonium sidoides which had been well pulverized by a pulverizer, and left at room temperature for 20 hours. Thereafter, the mixture was extracted with 8 kg of 6% by weight of an ethanol aqueous solution for 10 hours, followed by filtration. A dry residue of the filtrate was 1.78% by weight.

[0053]0.41 kg of maltodextrin was dissolved in 5 kg of the liquid extract, and this solution was dried under vacuum at 50° C. to obtain the stabilized dry powder of Pelargonium sidoides.

example 2

on of Liquid Formulation Including Stabilized Dry Powder of Pelargonium sidoides and Hedera helix Leaf Extract

[0057]A liquid formulation was prepared according to a composition of the following Table 1. Maltodextrin, a sorbitol solution, xylitol, potassium sorbate, xylitol, sucralose, and citric acid described in the following Table 1 were dissolved in purified water, and then the stabilized dry powder of Pelargonium sidoides (mixed dry powder of 11% ethanol extract and maltodextrin) prepared in Example 1 and 30% ethanol dry extract of Hedera helix leaf were added and dissolved, and sufficiently mixed and filtered to prepare the liquid formulation.

TABLE 1Example 2SectionComponentsg / 100 mLMain componentMixed dry powder of 11% ethanol1.144extract of Pelargoniumsidoides / maltodextrinMain component30% ethanol dry extract of Hedera0.389helix leafDiluentMaltodextrin0.432Sorbitol solution15.000PreservativePotassium sorbate0.117SweetenerXylitol7.000Sucralose0.020pH adjusterCitric acid0.040So...

experimental example 1

osite Liquid Formulation Including Pelargonium sidoides and Hedera helix Leaf Extracts

[0059]The composite liquid formulations including Pelargonium sidoides and Hedera helix leaf extracts of Example 2 and Comparative Example 2 were stored for 1 month to 3 months under long-term storage conditions of 25° C. / 60% relative humidity and under accelerated conditions of 40° C. / 75% relative humidity, and then contents of total phenolic compounds which are the index components of Pelargonium sidoides and hederacoside C which is the index component of Hedera helix leaf, which remained in each composite liquid formulation, were measured. Results are shown in the following Table 3 (unit: %).

TABLE 3Initial1 month3 monthsTotalTotalTotalphenolsHederacoside CphenolsHederacoside CphenolsHederacoside CLong-termExample 2100100100101.0103103storageComparative10010098.796.584.0100conditionsExample 2AcceleratedExample 210010098.010092.0102conditionsComparative10010092.895.866.097Example 2

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Abstract

Provided are a composite liquid pharmaceutical composition and a preparation method thereof, wherein the composite liquid pharmaceutical composition includes a Hedera helix leaf extract and a dry powder of a mixture including a Pelargonium sidoides extract and maltodextrin.

Description

TECHNICAL FIELD[0001]The present invention relates to a liquid pharmaceutical composition including a stabilized dry powder of Pelargonium sidoides, and specifically, to a composite liquid pharmaceutical composition including a stabilized dry powder of Pelargonium sidoides, in which storage stability of a main component of Pelargonium sidoides is improved during preparation of the composite liquid formulation, and a preparation method of the liquid pharmaceutical composition.BACKGROUND ART[0002]Respiratory diseases include respiratory infectious diseases such as the common cold, bronchitis, sinusitis, tonsillitis, sore throat, etc., asthma, bronchitis, chronic obstructive pulmonary disease, etc. These respiratory diseases are known to be attributed to inflammation caused by respiratory infections or immune responses. Although respiratory diseases vary in degree depending on specific diseases, they all cause a deterioration in quality of life. In severe cases, respiratory diseases re...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/08A61K36/25A61K36/185A61K47/36A61K9/00A61K47/26A61K47/12A61K9/06
CPCA61K9/08A61K36/25A61K36/185A61K47/36A61K2236/333A61K47/26A61K47/12A61K9/06A61K2236/331A61K9/0095A61K47/10A61K2300/00
Inventor KIM, KYOUNG RAKMOON, HONG SIKKIM, TAE WOOKKIM, SUNG JUNYU, SE MIYOON, YEONG CHEOLKIM, JONG HOON
Owner YANG JI CHEM CO LTD